ARROW HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB

Additional Manufacturer Narrative

(B)(4)

Description of Event or Problem

IT WAS REPORTED THAT: "DURING PLACEMENT OF A VASCATH FOR PATIENT NEEDING DIALYSIS IN THE MSICU, IT WAS DETECTED BY THE OPERATOR THAT THE CATHETER WOULD NOT PASS OVER THE GUIDEWIRE. WHEN THE WIRE WAS REMOVED IT WAS BENT AND UNRAVELING. THEY OBTAINED A SECOND KIT AND IT RECURRED". ASSOCIATED COMPLAINTS: 9680794-2026-00068 .

Additional Manufacturer Narrative

QN# (B)(4). THE CUSTOMER REPORT OF A DAMAGED GUIDEWIRE WAS CONFIRMED BY VISUAL INSPECTION OF THE CUSTOMER SUPPLIED PHOTO. THE IMAGE SHOWS A USED GUIDEWIRE WITH EVIDENCE OF UNRAVELING, HOWEVER, FULL COMPLAINT VERIFICATION TESTING TO DETERMINE THE CAUSE OF THE DAMAGE COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. ARROW GUIDEWIRES OF THIS SIZE ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE OF 2.75 POUNDS FORCE. THIS INTERNAL SPECIFICATION IS HIGHER THAN THE REQUIRED STANDARD OF 2.2 POUNDS FORCE FOR THIS SIZE WIRE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDEWIRE KINKING. GUIDEWIRE BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT: "DURING PLACEMENT OF A VASCATH FOR PATIENT NEEDING DIALYSIS IN THE MSICU, IT WAS DETECTED BY THE OPERATOR THAT THE CATHETER WOULD NOT PASS OVER THE GUIDEWIRE. WHEN THE WIRE WAS REMOVED IT WAS BENT AND UNRAVELING. THEY OBTAINED A SECOND KIT AND IT RECURRED". ASSOCIATED OMPLAINTS: 9680794-2026-00068 AND 9680794-2026-00069.